MEDICAL DEVICE ANCHORING SYSTEMS AND METHODS
An anchor assembly includes an anchoring member having a body portion. The anchoring member defines a longitudinal lumen in the body portion to slidably receive a portion of an electrode assembly. The anchor assembly also includes a shell assembly having first and second mating shell portions to be disposed on opposites sides of the anchoring member and to be coupled together to anchor the electrode assembly within the anchoring member. Each of the first and second mating shell portions includes a center portion and two lateral portions. The center portion fits over the anchoring member. The lateral portions of the first mating shell portion each have a prong member and the lateral portions of the second mating shell portion each have an aperture. The prong members and apertures mate to form a locking arrangement.
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This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 61/703,044 filed Sep. 19, 2012, which is incorporated herein by reference.
TECHNICAL FIELDThe present invention relates to medical devices and methods for implanting implantable medical devices. More specifically, the invention relates to devices and methods for securing implantable medical devices to a patient's anatomy.
BACKGROUNDThe implantation of various implantable medical devices requires securing the device to the patient's anatomy to prevent, or at least inhibit, unintended movement and/or migration of the implanted device. Exemplary such implantable medical devices include spinal stimulation leads, which are typically implanted adjacent to the patient's vertebral column and coupled to an implantable stimulator to provide selective nerve stimulation for pain management and the like. Such leads typically include a flexible insulative body and a compressible anchoring member disposed about the lead body. In a conventional implantation procedure, sutures or other ligatures manually tied around the anchoring member to secure the anchoring member, and consequently the lead disposed therein, to soft tissues proximate the patient's spinal column. In these applications, the anchoring member operates to delimit compressive forces on the lead itself imposed by the fixation sutures/ligatures.
In the illustrated embodiment, the anchoring member 25 has a body 42 with an outer surface 44 and a longitudinal lumen (not shown) through which a portion of the body 22 of the electrode assembly 15 is disposed. In addition, the anchoring member 25 includes a first end 45, an opposite second end 50, a longitudinal slot 55, a wing member 60 including a through hole 62, and a wing member 65 including a through hole 67. As shown, the wing members 60, 65 extend radially from the body 42 and are disposed generally diametrically opposite one another. In the various embodiments, the wing members 60, 65 operate to cooperate with a portion of a tissue fixation element, e.g., a suture loop or a suture/tissue anchor assembly, to secure the anchoring member 25. In such embodiments, the suture and/or tissue anchor can be inserted through the through hole 62 and/or 67 in the respective wing member 60, 65 and into the tissue to which the anchoring member 25 is desired to be affixed.
As further shown, the longitudinal slot 55 extends from proximate the first end 45 to proximate the second end 50, and further extends radially inward from the outer surface 44 to the longitudinal lumen, i.e., through the outer wall of material making up the body 42 of the anchoring member 25. Additionally, in the illustrated embodiments, the suture loops 35, 40 are disposed about the anchoring member 25 proximate the first end 45 and the second end 50 of the anchoring member body 42. In various embodiments, the suture loops 35, 40 can be positioned within circumferential grooves (not shown in
As shown in a comparison of
As further shown, the strain relief member 118 is attached to and positioned adjacent to the anchoring member 110. The strain relief member 118 also includes a longitudinal lumen (not shown) sized to slidably receive a portion of the body 122 of the implantable electrode assembly 115. As further shown, the strain relief member 118 is oriented to facilitate formation of a strain relief loop 160 in the body 122 of the electrode assembly 115 between the portions disposed, respectively, within the lumen of the anchoring member 110 and the strain relief member 118. As further shown, the strain relief member 118 includes a pre-curved portion 170 disposed adjacent to the body portion 120 of the anchoring member 110 between the ends 125, 130 thereof. The pre-curved portion 170 further facilitates forming the strain relief loop 160 in the body 122 of the electrode assembly 115.
In use, the anchoring member 110 is configured to operate as an anchoring element that forms a friction fit against the body 122 of the electrode assembly 115 disposed within the lumen of the anchoring member 110. The body portion 120 of the anchoring member 110 is configured to be sutured and secured to tissue (e.g., muscle, fascia, connective tissue, or bony) to secure the electrode assembly 115 in the desired location. At the same time, the strain relief member 118 is configured to facilitate formation of and maintenance of the strain relief loop 160 in the electrode assembly body 122. In the various embodiments, the lumen of the strain relief element 118 is configured to provide a slip fit against the body 122 of the electrode assembly 115, which allows the strain relief loop 160 to move, isolating the proximal end of the electrode assembly 115 from its distal end, which is positioned by the clinician so the electrodes will deliver current to the proper location.
In the various embodiments, the anchoring members 225, 226 and corresponding strain relief members 228, 229 are configured in substantially the same way as the anchoring member 110 and the strain relief member 118 of the anchor assembly 100 described above, and thus have substantially the same or identical functionality. That is, the anchoring member 225 is configured to facilitate securing an electrode assembly 215a to tissue, and the anchoring member 226 is configured to facilitate securing an electrode assembly 215b to tissue. In addition, the anchoring member 225 is configured to receive and frictionally engage a portion of a body 222a of the electrode assembly 215a, while the strain relief member 228 is configured to slidably receive and facilitate formation of a strain relief loop 243 in the body 222a of the electrode assembly 215a. Similarly, the anchoring member 226 is configured to receive and frictionally engage a portion of a body 222b of the electrode assembly 215b, while the strain relief member 229 is configured to slidably receive and facilitate formation of a strain relief loop 244 in the body 222b of the electrode assembly 215b. The anchoring assembly 200 thus provides an efficient, compact means for anchoring a pair of electrode assemblies to tissue while facilitating the formation of a strain relief loop in each of the electrode assemblies to enhance the reliability and long term stability of the implanted electrode assemblies. In various embodiments, the anchoring assembly 200 can be manufactured in a unitary form—e.g., from a single molding. In other embodiments, each of the respective anchoring members and strain relief members can be separately formed and subsequently assembled and attached together to form the complete anchoring assembly 200.
As shown, the wing members 545, 550 and the longitudinal slots 555, 560 are disposed substantially diametrically opposite one another. As further shown, the longitudinal slots 555, 560 each extend from proximate the end 535 to proximate the end 540 radially through the wing members 545, 550, respectively and the outer surface 530 into the lumen 572. As can be seen in
As further shown, particularly in
In the assembled anchor assembly 500, the shell portions 580, 590 are positioned opposite one another with the anchoring member 510 sandwiched therebetween. Additionally, the prong members 605, 608 extend through the through holes 552, 547, respectively of the wing members 550, 545 of the anchoring member 510, and further through the apertures 599, 598 of the shell portion 580. The assembled shell portions 580, 590 operate to radially compress the body portion 525 of the anchoring member 510 about a portion of an implantable device disposed within the lumen 572 of the anchoring member 510. In the various embodiments, each of the prong members 605, 608 includes a resilient end portion that can radially expand to a diameter larger 599, 598 through which it is fully inserted, so as to inhibit spontaneous separation of the portions 580, 590 of the outer shell assembly 520 once engaged. The prong members 605, 608 and the corresponding apertures 599, 598 thus form a locking arrangement for maintain the shell assembly 520 in its assembled state, which locking arrangement is reversible (e.g., by an appropriately designed instrument) to allow the shell assembly 520 to be separated, e.g., to reposition the anchoring member 510 as desired.
The various anchoring members described herein can be made from a variety of resilient, biocompatible materials, e.g., silicone rubber, polyurethane, polyether block amides, and the like. In various embodiments, when present, the shell assembly 520 of the anchoring assembly 500 can be made of a biocompatible, relatively rigid or semi-rigid polymeric or metallic materials such as, for example, polyether etherketone (PEEK™), polyethylene teraphthalate (PET), acrylics, polycarbonates, engineering plastics; and/or composites, as well as nickel, titanium, and alloys thereof.
Referring now to
Suture assembly 870 broadly includes a first suture portion 872 and tissue anchor portion 874. First suture portion 872 is a continuous length of suture forming a distal suture element 875 and proximal suture element 876. Proximal suture element 876 terminates in knotted loop 878 at the proximal end thereof which functions as a manual pull. As can be best seen in
Referring now to
Although the present invention has been described with reference to various embodiments, those of ordinary skill in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the inventions disclosed herein.
Claims
1. An anchor assembly, comprising:
- an anchoring member comprising a body portion having a first end and a second end opposite the first end, the anchoring member defining a longitudinal lumen in the body portion extending from the first end to the second end and configured and arranged to slidably receive a portion of an electrode assembly; and
- a shell assembly comprising first and second mating shell portions configured and arranged to be disposed on opposites sides of the anchoring member and to be coupled together to anchor the portion of the electrode assembly within the anchoring member, each of the first and second mating shell portions comprising a center portion and two lateral portions extending from the center portion, wherein the center portion fits over the anchoring member with the lateral portions of the first and second mating shell portions opposite each other, wherein the lateral portions of the first mating shell portion each have a prong member and the lateral portions of the second mating shell portion each have an aperture, wherein the prong members and apertures are configured and arranged for mating to form a locking arrangement.
2. The anchor assembly of claim 1, wherein the body portion of the anchoring member defines a longitudinal slot through an outer surface of the body portion and extending radially inward to the longitudinal lumen.
3. The anchor assembly of claim 1, wherein the anchoring member further comprises two opposing wing members extending from the body portion, each of the wing members defining a through hole.
4. The anchor assembly of claim 3, wherein each wing member comprises two opposing wing member portions separated by a bisecting slot.
5. The anchor assembly of claim 4, wherein the bisecting slot of at least one wind member extends to the longitudinal slot of the body portion of the anchoring member.
6. The anchor assembly of claim 4, wherein the lateral portions of the first and second mating portions of the shell assembly are configured and arranged to be positioned over the wing member portions of the anchoring member and to radially compress the body and the wing member portions of the anchoring member when the first and second mating portions are mated.
7. The anchor assembly of claim 4, wherein the shell assembly is configured and arranged so that the prong members of the lateral portions of the first mating portion pass through the through holes of the two opposing wing members when the shell assembly is disposed on opposite sides of the anchoring member and the first and second mating portions are mated.
8. An anchor assembly, comprising:
- an anchoring member comprising a body portion having a first end and a second end opposite the first end, the anchoring member defining a longitudinal lumen in the body portion extending from the first end to the second end and configured and arranged to slidably receive a portion of an electrode assembly, the anchoring member further defining a longitudinal slot through an outer surface of the body portion from the first end to the second end and extending radially inward to the longitudinal lumen and configured and arranged to receive a pin in the longitudinal slot, the anchoring member further comprising at least one wing member extending from the body portion and defining at least one anchor through hole.
9. The anchor assembly of claim 8, further comprising
- a disc defining a disc through hole; and
- a suture assembly for suturing the anchoring element to patient tissue, the suture assembly comprising a first suture portion and a tissue anchor portion, the first suture portion comprising a distal suture element and a proximal suture element, the proximal suture element comprising a knotted loop terminating the proximal suture element, the distal suture element comprising a suture loop and an adjustable locking knot completing the suture loop, wherein the suture loop comprises a terminating end secured by the disc with the suture loop and proximal suture element sliding freely through the disc through hole, and the tissue anchor portion comprising a proximal end woven through the suture loop and a distal end comprising a suture needle terminating the distal end.
10. The anchor assembly of claim 8, further comprising a pin configured and arranged for insertion into the longitudinal slot of the body portion of the anchoring member.
11. The anchor assembly of claim 8, wherein the pin comprises a handle portion.
12. The anchor assembly of claim 9, wherein the adjustable locking knot is a Weston knot or a Roeder knot.
13. An anchor assembly, comprising:
- a first anchoring member comprising a body portion having a first end and a second end opposite the first end, the first anchoring member defining a longitudinal lumen in the body portion extending from the first end to the second end and configured and arranged to slidably receive a first portion of a first electrode assembly; and
- a first strain relief member attached to and positioned adjacent to the first anchoring member, the first strain relief member defining a longitudinal lumen configured and arranged to receive a second portion of the first electrode assembly, wherein the first strain relief member is oriented with respect to the first anchoring member to facilitate formation of a strain relief loop in the first electrode assembly between the first and second portions of the first electrode assembly.
14. The anchor assembly of claim 13, wherein the first anchoring member further comprises a first wing member extending from the body portion, the first wing member defining a first through hole.
15. The anchor assembly of claim 14, wherein the first anchoring member further comprises a second wing member extending from the body portion diametrically opposite from the first wing member, the second wing member defining a second through hole.
16. The anchor assembly of claim 13, wherein the first strain relief member comprises a pre-curved portion disposed adjacent to the body portion of the first anchoring member, wherein the pre-curved portion facilitates formation of the strain relief loop.
17. The anchor assembly of claim 16, wherein the pre-curved portion of the first strain relief member is attached to the body portion of the first anchoring member.
18. The anchor assembly of claim 13, further comprising
- a second anchoring member attached to the first anchoring member and comprising a body portion having a first end and a second end opposite the first end, the second anchoring member defining a longitudinal lumen in the body portion extending from the first end to the second end and configured and arranged to slidably receive a first portion of a second electrode assembly; and
- a second strain relief member attached to and positioned adjacent to the second anchoring member, the second strain relief member defining a longitudinal lumen configured and arranged to receive a second portion of the second electrode assembly, wherein the second strain relief member is oriented with respect to the second anchoring member to facilitate formation of a strain relief loop in the second electrode assembly between the first and second portions of the second electrode assembly.
19. The anchor assembly of claim 13, further comprising the first electrode assembly, the first electrode assembly comprising an elongate, flexible body, wherein the first and second portions of the first electrode assembly are part of the elongate, flexible body.
20. The anchor assembly of claim 19, wherein the first portion of the first electrode assembly is radially compressed within the longitudinal lumen of the first anchoring member and the second portion of the first electrode assembly is slip fit within the longitudinal lumen of the first strain relief member, the body of the first electrode assembly forming a strain relief loop between the first and second portions of the first electrode assembly.
Type: Application
Filed: Sep 17, 2013
Publication Date: Mar 20, 2014
Applicant: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION (Valencia, CA)
Inventors: Ishmael Bentley (Eagan, MN), Lawrence W. Wales (Maplewood, MN), Jeffrey J. Peters (Excelsior, MN)
Application Number: 14/029,118